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Recruiting Not applicable NCT07362160

Clear Orthodontic Expander Versus Hyrax

No applicable phase (e.g. observational)
Conditions: Malocclusion Narrow Maxilla

Sponsor: University of Baghdad

trial.available_in: БГ
Overview
This study will be conducted to evaluate the effectiveness of a clear expander fabricated from 2-mm biocompatible polyethylene terephthalate glycol (PETG) thermoforming material integrated with an expansion screw in achieving dental and skeletal expansion in adolescent patients, compared with the conventional Hyrax expander.
Description
This will be a multicenter randomize clinical trial with two-arm parallel groups, and will be conducted at the Department of Orthodontics, College of Dentistry, University of Baghdad, as well as different specialized dental centers affiliated with the Iraqi Ministry of Health, and some private clinics. The sample size will be calculated based on previous studies with similar aim to measure the skeletal expansion. A minimum sample size of 17 patients was required, and in order to account for a 15% dropout, a total of 20 patients will be recruited for each group (new clear expander and hyrax expander). The amount of 2.5 mm or greater of maxillary sutural opening will be considered clinically effective. Two randomizations will be employed, one for the expander type and the other for the cleaning method of the new expander, a computer random generator will be used to develop a simple randomization with an equal allocation ratio (1:1) and without stratification. Data Collection and Measurements will be include, CBCT evaluation, Intraoral scan of the maxillary arch evaluation, overjet and overbite, CBCT-derived cephalometric images will be used to measure the maxillary mandibular plane angle, Microbial evaluation after using two different methods for cleaning the new clear expander and at the end of the treatment, the patient will be asked to fill out a questionnaire about the treatment, giving information about their experience and satisfaction during treatment. Data will be analyzed using the Statistical Package for Social Sciences for Windows, version 26.0, including Descriptive Statistics 9numbers, frequencies, percentages, mean, median, and standard deviations), Reliability Statistics (an intraclass correlation coefficient), and Inferential Statistics (Levene's test, Shapiro Wilk test, Paired samples t-test and Independent samples t-test).
Who can participate
Inclusion Criteria: 1. Patients' age at the start of treatment will range from 10-14 years. 2. Unstable unilateral or bilateral posterior crossbite due to maxillary constriction. 3. The first molars are fully erupted. 4. Good oral health free from caries and periodontal problems at the start of treatment. 5. Good general health. Exclusion Criteria: 1. Patients with obvious facial asymmetry. 2. Patients with orofacial cleft. 3. Patients with previous orthodontic treatment. 4. Patients with bad oral habits. 5. Patients with active periodontal disease.
Interventions
New clear expander
DEVICE
Hyrax expander
DEVICE
Locations 1
Iraq (1)
University of Baghdad/Collage of Dentistry
Baghdad , Al-Rusafa, Bab Al-moadham
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
10 Years
Maximum age
14 Years
Healthy volunteers
No
Start date
01.02.2026
Completion date
01.02.2027
Registry ID
NCT07362160
Source
clinicaltrials.gov
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